Study Comparing Radiation Therapy and Chemotherapy With or Without Nimotuzumab

NCT ID: NCT01345084

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2017-11-30

Brief Summary

Primary: to compare the overall survival defined as the time elapsed between the randomization date and death due to any cause, in both treatment groups.

Secondary: to compare the progression-free survival, incidence of locoregional failure, site of the first recurrence/progression, objective response rate assessment, quality of life assessment and incidence of adverse events.

Detailed Description

This is a phase III, superiority, national, open-label, randomized, and two-arm study.

Patients' enrollment will be performed only after approval by competent regulatory authorities and it will last up to 12 months.

All patients taking part in the study must sign an informed consent. The patients will have stage III or IV, unresectable head and neck SCC, performance status 0 or 1.

Randomization and treatment assignment will be performed by a company specifically contracted for such purpose and will be per research site and disease stage, 1:1

Conditions

Carcinoma; Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiation therapy, cisplatin and nimotuzumab

Nimotuzumab - (Diluted into 250 mL of sodium chloride sterile solution 0.9% in intravenous infusion for 30 minutes. Pre-drugs are optional, at the investigator's discretion)- 200 mg, IV, weekly doses during the radiation therapy until completing 6 months.

Radiation therapy- 66 -70 Gy, external,fractions of 2 Gy per day, 5 days a week

Cisplatin - 75 mg/m2, IV, Doses every 3 weeks (a total of three doses)

Group Type: EXPERIMENTAL

Nimotuzumab

Intervention Type: DRUG

200 mg, IV, weekly doses during the radiation therapy until completing 6 months (Diluted into 250 mL of sodium chloride sterile solution 0.9% in intravenous infusion for 30 minutes).

Radiation therapy and cisplatin

Radiation therapy: 66- 70 Gy, fractions of 2 Gy per day, 5 days a week

Cisplatin:75 mg/m2, IV, doses every 3 weeks (a total of three doses)

Group Type: ACTIVE_COMPARATOR

Radiation Therapy

Intervention Type: RADIATION

66- 70 Gy External, Fractions of 2.0 Gy per day, 5 days a week

Cisplatin

Intervention Type: DRUG

75 mg/m2, IV, doses every 3 weeks (a total of three doses)

Interventions

Radiation Therapy

66- 70 Gy External, Fractions of 2.0 Gy per day, 5 days a week

Intervention Type: RADIATION

Nimotuzumab

200 mg, IV, weekly doses during the radiation therapy until completing 6 months (Diluted into 250 mL of sodium chloride sterile solution 0.9% in intravenous infusion for 30 minutes).

Intervention Type: DRUG

Cisplatin

75 mg/m2, IV, doses every 3 weeks (a total of three doses)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Aged 18 to 75 years old;
• Histological or cytological confirmation of SCC in oral cavity, oropharynx, hypopharynx, or larynx;
• Stages III or IV disease
• Unresectability according to responsible surgeon or medical staff's opinion;
• Performance status 0 or 1
• Present indication for radiation therapy and chemotherapy treatment with cisplatin;
• Adequate hepatic, renal and medullar functions, indicated by:
• Life expectancy above 6 months.

Exclusion Criteria

• Presence of nasopharyngeal, paranasal sinuses, or salivary glands carcinoma;
• Presence of known distant metastasis;
• Presence of any other active neoplasm or history of any tumor diagnosed in the last 5 years
• Patients with inability to eat normally, in whom a gastric or enteral tubing was not possible at least 2 weeks before their enrollment in the study;
• Previous treatment with chemotherapy, radiation therapy, or EGFR inhibitors of any pharmacological class;
• Presence of serious comorbidity that, in the investigator's opinion, will put the patient at risk or will jeopardize protocol compliance;
• Active known seropositivity for HIV, hepatitis B or C
• Presence of a significant neurological or psychiatric disease, as per the investigator's judgment;
• Hypersensitivity or allergy to any of the study treatments;
• Presence of uncontrolled hypercalcemia;
• Pregnancy or breastfeeding;
• Female patients of childbearing potential who wish to become pregnant or are unwilling, as well as their partners, to use an appropriate contraceptive method throughout the study period;
• Participation in any clinical trial in the last 12 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gustavo Girotto

Role: PRINCIPAL_INVESTIGATOR

Hospital de Base São José do Rio Preto

Locations

Hospital Erasto Gaetner

Curitiba, Paraná, Brazil

Hospital Federal de Bonsucesso

Rio de Janeiro, Rio de Janeiro, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo, Brazil

Hospital Amaral Carvalho

Jaú, São Paulo, Brazil

Centro Oncológico de Mogi das Cruzes

Mogi das Cruzes, São Paulo, Brazil

Hospital de Base São José do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Instituto do Câncer de São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

EF 118

Identifier Type: -

Identifier Source: org_study_id